Comprehensive Nano Stemless Shoulder
FDA 510(k) K182516 · Biomet Manufacturing Corp
510(k) numberK182516
Submission
- Device name
- Comprehensive Nano Stemless Shoulder
- Applicant
- Biomet Manufacturing Corp
Warsaw, IN, US - Received
- September 13, 2018
- Decision date
- April 22, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PKC – Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
Replacement of the humeral head for total anatomic shoulder arthroplasty
Other 510(k)s with product code PKC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254154 | FX V135 EASYTECH® Shoulder SystemPKC · Traditional | FX Shoulder Solutions, Inc. | 05/01/2026SE |
| K252129 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | Smith & Nephew, Inc. | 10/03/2025SE |
| K243248 | Inhance IntactPKC · Traditional | Depuy Ireland UC | 12/23/2024SE |
| K241873 | OsseoFit Stemless Shoulder SystemPKC · Traditional | Zimmer, Inc. | 12/11/2024SE |
| K240716 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | Smith & Nephew, Inc. | 11/20/2024SE |
| K221758 | SMR Stemless AnatomicPKC · Traditional | Lima Corporate S.P.A. | 03/17/2023SE |
| K220418 | Tornier Perform Humeral System StemlessPKC · Traditional | Tornier, Inc. | 09/14/2022SE |
| K213615 | Shoulder Innovations Total Shoulder SystemPKC · Traditional | Shoulder Innovations, Inc. | 03/11/2022SE |
| K212683 | GLOBAL ICON Stemless Shoulder SystemPKC · Traditional | Depuy(Ireland) | 01/19/2022SE |
| K203108 | Ignite Stemless Anatomic Shoulder SystemPKC · Traditional | Ignite Orthopedics, LLC | 07/16/2021SE |
More from Ignite Orthopedics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K230540 | Patient Specific Planning Solution 3D Bone ModelsLLZ · Traditional | 07/25/2023SE |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemPHX · Traditional | 03/15/2023SE |
| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E LinerPHX · Traditional | 11/04/2021SE |
| K202232 | Comprehensive Vault Reconstruction SystemPHX · Traditional | 02/19/2021SE |
| K193038 | Comprehensive Shoulder SystemMBF · Traditional | 10/28/2020SE |
| K181611 | Comprehensive Reverse Shoulder SystemPHX · Traditional | 09/24/2018SE |
| K173411 | Comprehensive Segmental Revision System (SRS)PHX · Traditional | 02/08/2018SE |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…PHX · Traditional | 01/03/2018SE |
| K163651 | ExpressBraid Graft ManipulationGAT · Traditional | 02/17/2017SE |
| K152754 | Comprehensive Vault Reconstruction System (VRS)PHX · Traditional | 05/16/2016SE |
Questions and answers
When was Comprehensive Nano Stemless Shoulder cleared by the FDA?
Comprehensive Nano Stemless Shoulder (K182516) received a 510(k) decision of Substantially Equivalent on April 22, 2019, 221 days after the submission was received.
What is the product code of K182516?
The FDA product code is PKC – Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained, a Class II (moderate risk) device regulated under 21 CFR 888.3660.